Clinical Progression of Mild to Moderate Idiopathic Pulmonary Fibrosis (IPF) Under a Therapy With Esbriet® (Pirfenidone)

Hoffmann-La Roche12 enrolled

Overview

The purpose of the study was to assess the clinical outcome of patients with a mild to moderate IPF after a one-year therapy with Esbriet® (Pirfenidone).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

PirfenidoneDRUG

This is an observational study. Pirfenidone is available as an 267 mg capsule for oral administration.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: Adult patients with confident diagnosis of mild to moderate IPF, who had previously not yet been treated with Pirfenidone Exclusion Criteria: Hypersensitivity to the active substance or one of the other excipients of Pirfenidone Concomitant use of Fluvoxamin Severe hepatic impairment or end stage liver disease Severe renal impairment (Creatinine-Clearance \<30 ml/min) or end stage renal disease requiring dialysis Simultaneous participation in interventional studies Previously treated with Pirfenidone for longer than 30 days

Locations (17)

Praxis Dr. med. Mathias Rolke und Dr. med. Peter Rückert

Aschaffenburg, Germany

Evang. Lungenklinik Berlin Klinik für Pneumologie

Berlin, Germany

Outcomes

Primary Outcomes

Categorical Decrease Of The Vital Capacity And Forced Volume Capacity (>= 5 % Respectively 10% Compared To The Previous Examination Findings) Under Treatment

Time frame: -3 to 8 months before inclusion, appointment 0, and 3, 6, 9 and 12 months after appointment

Categorical Decrease of the 6-Minute Walking Distance (>= 50 Metres Compared to the Previous Examination Findings) Under Treatment